Surgical instrument access device

ABSTRACT

Embodiments of an access device system useful for single or limited port procedures includes a retractor and a gel cap removably coupled to the retractor. The gel cap includes a gel pad that acts as an artificial body wall, through which instruments may be inserted into a body cavity, either directly or through one or more trocars. The gel pad permits flexible instrument placement, as well as translational and angular degrees of freedom for the instruments while maintaining a gas tight seal.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Application No. 61/022,772,filed Jan. 22, 2008, and U.S. Application No. 61/104,963, filed Oct. 13,2008, the entire disclosures of which are incorporated by reference.

BACKGROUND

1. Technical Field

This application is generally directed to surgical devices, and moreparticularly, to an artificial body wall useful in single-portlaparoscopic surgical procedures.

2. Description of the Related Art

Access devices are commonly used in surgery to facilitate theintroduction of various surgical instruments into natural biologicalvessels, conduits, orifices, cavities, and other interior regions of thebody. These access devices include, for example, devices that facilitatethe introduction of a needle into a vessel, and trocars that facilitatethe introduction of laparoscopic instruments into the abdomen of thebody.

Some of these access devices are introduced into regions that include afluid or gas under pressure. In the case of a needle access device, thepressure may be from a liquid, such as blood. In the case of a trocar,the pressure may be from a gas, such as an insufflation gas. In eithercase, it is desirable to provide for the introduction of the surgicalinstrument into the cavity without permitting the escape of thepressurized fluid or gas.

In the case of trocars, a cannula at the distal end of the trocar istypically connected to a seal housing at the proximal end of the trocar.Together the cannula and housing form a working channel through whichvarious instruments can be inserted to access the cavity. Sealmechanisms are commonly disposed in the housing and include a septumvalve that seals the working channel when an instrument is in place, anda zero closure valve that seals the working channel when the instrumentis removed.

Current surgical access ports allow for single instrument access througheach port, or allow for multiple instrument access through a rigidcannula. Some devices, such as transanal endoscopic microsurgery (TEMS)units, require that instruments be placed through fixed points locatedon the device, and also require that the device be attached to thesurgical table to support the weight of the device, as well as to locatethe position of the device respective to the patient. These devices donot provide flexibility to the surgeon in selecting instrument size, andthey restrict instrument movement with their rigid cannulas.Additionally, surgeons are performing laparoscopic surgical proceduresthrough a single or a limited number of access ports. In theseprocedures, the surgeon to places multiple instruments through a singleor a limited number of access ports. The procedures may be performedthrough a single two (2) centimeter incision at the umbilicus, or incertain cases, trans-vaginally or trans-anally. What is needed is asystem that meets the needs of these new procedures and allows moreoptions for the surgeons.

SUMMARY OF THE INVENTION

Embodiments of an access device system useful for single or limited portprocedures comprises a retractor and a gel cap removably coupled to theretractor. The gel cap comprises a gel pad that acts as an artificialbody wall, through which instruments may be inserted into a body cavity,either directly or through one or more trocars. The gel pad permitsflexible instrument placement, as well as translational and angulardegrees of freedom for the instruments while maintaining a gas tightseal.

Accordingly, some embodiments provide a surgical access port adapted forperforming laparoscopic surgical procedures at a single access sitewherein an incision is made in the abdominal wall of a patient and theabdominal cavity is pressurized with an insufflation gas, the accessport adapted to provide access to the abdominal cavity for surgicalprocedures while maintaining insufflation pressure in the abdominalcavity, the surgical access port comprising: an adjustable woundretractor comprising: a proximal ring, wherein the proximal ring isconfigured to be disposed proximate the outer surface of the abdominalwall of the patient and substantially surround the incision; aretraction sheath comprising a tubular wall, a proximal portion coupledto the proximal ring during use, and a distal portion, wherein theretraction sheath is configured to be disposed through the incision andline the incision, and wherein the retraction sheath is adjustable toretract the incision; and a distal ring coupled to the distal portion ofthe retraction sheath, wherein the distal ring is configured to bedisposed proximate the inner surface of the abdominal wall andsubstantially surround the incision; and a gel cap configured to becoupled to the proximal ring, comprising: a cap ring, wherein the capring is configured to substantially surround the incision; a gel paddisposed within the cap ring; and a plurality of sealing valvesoperatively attached to the gel pad, wherein the plurality of sealingvalves at least partially form a plurality of access channels throughthe gel pad, and wherein the plurality of sealing valves are configuredto form seals with instruments extending through the sealing valves andform seals in the absence of any instruments extending through thesealing valves.

In some embodiments, at least a portion of at least one of the sealingvalves defines an orifice. In some embodiments, at least a portion of atleast one of the sealing valves comprises a septum seal. In someembodiments, at least a portion of at least one of the sealing valvescomprises a duck bill valve. In some embodiments, at least one of thesealing valves has a low profile. In some embodiments, at least one ofthe sealing valves has a first size to accommodate an instrument of thefirst size, and at least another of the sealing valves has a second sizeto accommodate an instrument of the second size.

In some embodiments, at least one of the sealing valves is configuredsuch that the sealing valve is repositionable relative to the cap ringduring use. In some embodiments, at least one of the sealing valves isconfigured such that the sealing valve is translatable relative to thecap ring during use. In some embodiments, at least one of the sealingvalves is configured such that the sealing valve is pivotable relativeto the cap ring during use. In some embodiments, at least one of thesealing valves is configured such that the sealing valve is heldgenerally stationary relative to the cap ring during use.

In some embodiments, the gel cap is configured to be removably coupledto the proximal ring during use. In some embodiments, the gel cap isfixed to the proximal ring.

In some embodiments, the proximal ring of the wound retractor isrotatable to adjustably retract the incision during use. In someembodiments, the retraction sheath is stretchable to adjustably retractthe incision during use.

Some embodiments additionally comprise a tether coupled to the distalring. In some embodiments, at least a portion of the distal ring has anon-circular cross section that facilitates folding the distal ring andinsertion through the incision. In some embodiments, the distal ring hasa tear-drop-shaped cross section that facilitates folding the distalring and insertion through the incision. In some embodiments, the distalring comprises at least one notch that facilitates folding of the distalring and insertion through the incision.

Some embodiments provide a surgical access port adapted for performing asurgical procedure at an access site wherein a body cavity of a patientis pressurized with an insufflation gas, the access port adapted toprovide access to the body cavity for surgical procedures whilemaintaining insufflation pressure in the body cavity, the surgicalaccess port comprising: an adjustable retractor comprising: a proximalring, wherein the proximal ring is configured to be disposed proximatethe outer surface of the body wall of the patient; a retraction sheathcomprising a tubular wall, a proximal portion coupled to the proximalring during use, and a distal portion, wherein the retraction sheath isconfigured to be disposed through an opening in the body wall of thepatient, and wherein the retraction sheath is adjustable to retract theopening in the body wall; and a distal ring coupled to the distalportion of the retraction sheath, wherein the distal ring is configuredto be disposed proximate the inner surface of the body wall of thepatient; and a sealing cap configured to be coupled to the proximalring, comprising: a cap ring substantially surrounding a flexiblematerial disposed within the cap ring; and a sealing valve positionedwithin the cap ring and substantially surrounded by and operativelyattached to the flexible material, wherein the sealing valve at leastpartially forms an access channel through the flexible material, andwherein the sealing valve is configured to form a seal with aninstrument extending through the sealing valve and form a seal in theabsence of any instrument extending through the sealing valve.

In some embodiments, the flexible material comprises a gel.

In some embodiments, the sealing valve is repositionable relative to thecap ring during use. In some embodiments, the sealing valve istranslatable relative to the cap ring during use. In some embodiments,the sealing valve is pivotable relative to the cap ring during use.

In some embodiments, the sealing cap comprises a plurality of sealingvalves positioned within the cap ring and substantially surrounded bythe flexible material, wherein the plurality of sealing valves at leastpartially form a plurality of access channels through the flexiblematerial, and wherein the plurality of sealing valves are configured toform seals with instruments extending through the sealing valves andform seals in the absence of any instruments extending through thesealing valves.

Some embodiments additionally comprise a tether coupled to the distalring. In some embodiments, at least a portion of the distal ring has anon-circular cross section that facilitates folding the distal ring andinsertion through the incision.

Some embodiments provide a surgical access port adapted for performinglaparoscopic surgical procedures at an access site wherein an incisionis made in the abdominal wall of a patient and the abdominal cavity ispressurized with an insufflation gas, the access port adapted to provideaccess to the abdominal cavity for surgical procedures while maintaininginsufflation pressure in the abdominal cavity, the surgical access portcomprising: an adjustable wound retractor having a proximal ring, adistal ring, and a retraction sheath extending between the proximal ringand the distal ring, the proximal ring being configured to be disposedproximate the outer surface of the abdominal wall of the patient, thedistal ring being configured to be disposed proximate the inner surfaceof the abdominal wall of the patient, and the a retraction sheathcomprising a tubular wall having a proximal portion coupled to theproximal ring during use and a distal portion coupled to the distal ringduring use, wherein the retraction sheath is configured to be disposedthrough the incision and line the incision, and wherein the retractionsheath is adjustable to retract the incision; and a sealing capconfigured to be coupled to the proximal ring during use, the sealingcap comprising a plurality of sealing valves, wherein the plurality ofsealing valves at least partially form a plurality of access channelsthrough the sealing cap, wherein the plurality of sealing valves areconfigured to form seals with instruments extending through the sealingvalves and form seals in the absence of any instruments extendingthrough the sealing valves, and wherein at least one of the sealingvalves is repositionable relative to at least another one of the sealingvalves during use.

In some embodiments, the sealing cap comprises a gel.

In some embodiments, the at least one repositionable sealing valve istranslatable relative to the at least another one of the sealing valves.In some embodiments, the at least one repositionable sealing valve ispivotable relative to the at least another one of the sealing valves.

Some embodiments additionally comprise a tether coupled to the distalring. In some embodiments, at least a portion of the distal ring has anon-circular cross section that facilitates folding the distal ring andinsertion through the incision.

Some embodiments provide an access device system comprising: a retractorand a gel cap. The retractor comprises an inner ring, an outer ring, anda flexible sleeve extending between the inner ring and the outer ring.The outer ring comprises an outer component and an inner component,wherein the inner component defines an annular axis around which theouter component is rotatable, thereby winding and unwinding the flexiblesleeve therearound. The gel cap comprises an annular cap ring coupled tothe outer ring of the retractor and a gel pad disposed in and coupled tothe annular cap ring. The gel pad does not comprise a preformed accesschannel therethrough.

Some embodiments provide an access device system comprising: a retractorand a gel cap. The retractor comprises an inner ring, an outer ring, anda flexible sleeve extending between the inner ring and the outer ring.The outer ring comprises an outer component and an inner component,wherein the inner component defines an annular axis around which theouter component is rotatable, thereby winding and unwinding the flexiblesleeve therearound. The gel cap comprises an annular cap ring coupled tothe outer ring of the retractor and a gel pad disposed in and coupled tothe annular cap ring. At least one access port comprising a first sealand a second seal is at least partially embedded in the gel pad, whereinthe first seal comprises an instrument seal and the second sealcomprises a zero seal.

Some embodiments of the access device system further comprise a trocarcomprising a longitudinal axis defining an access channel; a proximalend; a distal end; a tubular cannula; a seal assembly disposed at theproximal end of the cannula; and a retainer disposed at the distal endof the cannula. The seal assembly comprises an instrument seal and azero seal. The proximal end of the retainer comprises a face that issubstantially perpendicular to the longitudinal axis. A diameter of theretainer convergently tapers from the proximal end to the distal endthereof.

Some embodiments provide a single port access device system comprising aretractor and an artificial body wall couplable to the retractor,wherein the artificial body wall comprises a plurality of accesschannels dimensioned and configured for instrument access therethrough,and wherein instruments inserted through the access channels arerelatively translatable and relatively pivotable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a patient in surgery illustrating an embodimentof the access device positioned on the abdomen and in use.

FIG. 2 is a cross-sectional side view illustrating an embodiment of theaccess device, with the wound retractor retracting the vagina of apatient, and the gel cap sealing the opening of the wound retractor.

FIG. 3 is a front view illustrating an embodiment of the access devicedeployed and in use at the mouth of the patient.

FIG. 4 is a top view illustrated a patient in the prone position with anembodiment of the access device deployed and in use at the anus of thepatient.

FIG. 5 is a perspective view of an embodiment of an access devicecomprising a cap and a retractor.

FIG. 6A is a partial side cross section of an embodiment of a retractor.FIGS. 6B-6D illustrate cross sections of embodiments of inner rings.

FIG. 7 is a partial side cross section of another embodiment of aretractor.

FIG. 8A is a side view of an embodiment of a retractor comprising atether. FIG. 8B is a side view of a method for removing the retractorillustrated in FIG. 8A.

FIG. 9A is a side view of an embodiment of an insertion/removal devicefor a retractor and a method for inserting a retractor. FIG. 9B is aside view of another embodiment of an insertion/removal device for aretractor and a method for inserting a retractor. FIG. 9C is a side viewof a method for removing a retractor using the device illustrated inFIG. 9B.

FIG. 10A is a top perspective view of an embodiment of a gel cap. FIG.10B is a bottom view of an embodiment of a cap ring.

FIG. 11A is a top view of an embodiment of a gel cap comprising aplurality of access ports embedded in the gel pad. FIG. 11B is a topperspective view of the gel cap illustrated in FIG. 11A. FIG. 11C is abottom perspective view of the gel cap illustrated in FIG. 11A.

FIG. 11D is a top perspective view of the gel cap illustrated in FIG.11A with instruments inserted through two of the access ports. FIG. 11Eis a bottom perspective view of the gel cap and instruments illustratedin FIG. 11D. FIG. 11F is a side view of the gel cap and instrumentsillustrated in FIG. 11D.

FIG. 11G is a top perspective view of an embodiment of gel capcomprising a fixed camera or laparoscope port.

FIG. 12 is a cutaway perspective view of an embodiment of an accessdevice system comprising a gel cap that snap fits to a retractor.

FIG. 13 is an exploded view of an embodiment of a trocar.

Similar components have similar reference numbers throughout.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Embodiments of the surgical instrument access device system are useful,for example, for single incision, single port, and/or limited portlaparoscopic surgical procedures, for example, abdominal (FIG. 1),transvaginal (FIG. 2), transoral (FIG. 3), and transanal (FIG. 4)procedures.

FIG. 5 illustrates a perspective view of an embodiment of an accessdevice system 5000 comprising a retractor 5100 and a cap 5500, which isuseful in single port and/or limited port procedures. The retractor orsurgical wound retractor 5100 is placed and/or positioned into, across,and/or through a surgical incision and/or body orifice to enlarge,reshape, and/or isolate the incision or body orifice. The cap 5500provides an artificial body wall through which instruments access theinterior of a patient's body, for example, a body cavity. The componentsof the access device 5000 comprise any suitable biologically compatiblematerials. Other embodiments of access device systems are described inU.S. Patent Publication No. 2007/0088204 A1, the disclosure of which isincorporated.

The embodiment of the retractor 6100 illustrated in a partial side crosssection in FIG. 6A comprises an inner or distal ring 6110, an outer orproximal ring 6120, and a sleeve or retraction sheath 6130 extendingbetween and coupling the inner ring 6110 and the outer ring 6120. Thesleeve 6130 comprises a flexible membrane, which is substantiallycylindrical in the illustrated embodiment. In other embodiments, thesleeve 6130 has another shape, for example, an oval cross section.Embodiments of the sleeve 6130 comprise a flexible, semi-transparentpolymer film. Some embodiments of the sleeve 6130 comprise one or morecoatings that provide additional functionality, for example, ananti-microbial coating.

Embodiments of the inner ring 6110 are sufficiently flexible andcompliant to be compressed and/or deformed for insertion through anincision and/or body orifice. When subsequently released within anassociated body cavity, the inner ring 6110 substantially returns to itsoriginal shape or footprint. In some embodiments, the inner ring 6110assumes a substantially circular shape in a relaxed state, for example,when released within a body cavity. In other embodiments, the inner ring6110 has another shape in the relaxed state, for example, an oval. Theinner ring 6110 assumes a different shape when compressed for insertionthrough an incision or body orifice, for example, a substantially ovalshape, a generally linear shape, a tear-drop shape, or another suitableshape. Those skilled in the art will recognize that in otherembodiments, the inner ring 6110 in the relaxed state has a shape otherthan round, for example, oval, elliptical, or D-shaped. In otherembodiments, the inner ring 6110 is substantially rigid, that is,non-compliant under the ordinary conditions under which it is used.

Embodiments of the inner ring 6110 comprise a circular cross section asillustrated in FIG. 6A. In other embodiments, the inner ring 6110comprises another cross-sectional shape, for example, at least one ofoval or elliptical (FIG. 6B), tear-drop shaped (FIG. 6C), and D-shaped(FIG. 6D). Those skilled in the art will understand that other crosssections are used in other embodiments. Some embodiments of the innerring 6110 comprise at least one notch and/or weak spot, which facilitatefolding or deforming the inner ring 6110, thereby facilitating insertionand/or removal of the inner ring 6110.

Some embodiments of the inner ring 6110 comprise one or more lumensextending therethrough. For example, the embodiment of the inner ring6110 illustrated in FIG. 6A comprises a lumen 6112. Embodiments of thelumen 6112 provide at least one of improved resilience and improvedflexibility. In some embodiments a wire is disposed within the lumen6112, for example, a spring-metal wire, thereby modifying the resilienceof the inner ring 6110. In some embodiments, the lumen or lumens 6112improve the compressibility of the inner ring 6110, thereby facilitatinginsertion into and/or removal from a body cavity. For example, in someembodiments, the lumen(s) 6112 increase the flexibility of the innerring 6110, for example, permitting a smaller radius fold and/or aflatter compressed state. In some embodiments, a more flexible innerring 6110 improves sealing of the retractor to an inner wall of the bodycavity. In some embodiments, an inner ring 6110 comprising one or morelumens 6112 compresses to a smaller size and/or cross section than asimilar inner ring 6110 without a lumen, for example, by collapsing thelumen(s) 6112 in the compressed state.

In some embodiments, the inner ring 6110 is manufactured as a monolithicring or toroid. In other embodiments, the inner ring 6110 ismanufactured from a generally linear body comprising a first end and asecond end, which are brought together to provide a closed form. Thefirst end and second end are then joined using any suitable means ormethod known in the art, for example, by at least one of adhesively,welding, melting, mechanically, and the like. In some embodiments, thefirst end and second end of the linear body are joined using a coupler.In some embodiments, the coupler engages the lumen 6112, for example,comprising a first finger and a second finger dimensioned to be receivedwithin the lumen 6112 at the first end and the second end of the body,respectively, where the first and second fingers and extend in oppositedirections from a common locus of the coupler. In embodiments, thecoupler prevents relative rotation between the first end and the secondend of the body of the coupler.

Returning to FIG. 6A, the outer ring 6120 includes an outer component6122 and an inner component. In the illustrated embodiment, the outercomponent 6122 has a substantially circular footprint and asubstantially oval cross section. In other embodiments, the outercomponent 6122 has another cross-sectional shape, for example,rectangular, hexagonal, octagonal, or another suitable shape. In theillustrated embodiment, a cross-sectional height of the outer component6122 is larger than a cross-sectional width thereof. In someembodiments, a ratio between the height and width of the cross-sectionrelates to factors including an overall hardness and/or rigidity of theouter component 6122 and a diameter of the outer ring 6120. Moreparticularly, a softer outer component 6122 correlates with a largerratio between the cross-sectional height and width of the outercomponent 6122 in some embodiments. Similarly, increasing the diameterof the outer component 6122 increases the ratio between thecross-sectional height and width of the outer component 6122.Embodiments of the outer component 6122 comprise a thermoplasticelastomeric material, such as a thermoplastic polyester elastomer and/ora thermoplastic polyether ester elastomer (HYTREL®, DuPont, Wilmington,Del.) and/or a thermoplastic polyurethane elastomer (PELLETHANE®, DowChemical, Midland, Mich.). Embodiments of the outer component 6122 areextruded, injection molded, compression molded, or over-molded. Someembodiments of extruded outer components 6122 have the ends producedthereby heat sealed together.

In the embodiment illustrated in FIG. 6A, the outer component 6122 ofthe outer ring comprises three lumens 6124—a first or middle lumen 6124a, a second or top lumen 6124 b, and third or bottom lumen 6124c—extending circumferentially therethrough. In some embodiments, one orboth of the top lumen 6124 b and bottom lumen 6124 c are optional. Themiddle lumen 6124 a is disposed about at the center of the outercomponent 6122, substantially at the intersection of the major and minoraxes of the oval cross section thereof. The top lumen 6124 b is disposedsubstantially on the major axis, on a first side of the minor axis orabove the middle lumen 6124 a. The bottom lumen 6124 c is disposedsubstantially on the major axis, on a second side of the minor axis orbelow the middle lumen 6124 a. The middle lumen 6124 a has an ovalcross-section and is larger than the top lumen 6124 b and the bottomlumen 6124 c in the illustrated embodiment. The top lumen 6124 b andbottom lumen 6124 c each has a tear-dropped cross-section comprising atapered portion disposed away from the middle lumen 6124 a. In otherembodiments, each of the lumens 6124 independently has anothercross-sectional shape, for example, a generally circular cross section.In some embodiments, the cross-sectional shape of a lumen 6124 reducescontact between the lumen 6124 and an inner component (discussed below)disposed therein, thereby reducing friction and/or drag therebetween.For example, in some embodiments, the lumen 6124 has a polygonal crosssection, for example, generally square, rectangular, diamond-shaped,hexagonal, star-shaped or the like. In some embodiments, a wall of thelumen is textured, thereby reducing contact and friction with an innercomponent disposed therein.

Some embodiments of the outer component 6122 of the outer ring comprisea split member, such as a substantially straight member having a firstend and a second end. The first and second ends of the member arebrought proximate each other and coupled together, as will be discussedin more detail below.

Some embodiments of the inner component of the outer ring comprise agenerally circular rigid wire 6126. In other embodiments, the rigid wirehas another shape, for example, generally oval or elliptical. In theillustrated embodiment, the inner component is disposed in the middlelumen 6124 b of the outer component 6122. The wire 6126 of the innercomponent is not compliant or resilient relative to the body tissue ofthe surgical incision or natural body orifice. Accordingly, the wire6126 does not flex, yield, and/or deform relative to the body tissue ofthe surgical incision or natural body orifice during retraction of theincision or body orifice. In the illustrated embodiment, the rigid wire6126 defines the peripheral shape or footprint, of the outer ring 6120of the wound retractor. The rigid wire 6126 serves as an axle. annularaxis, or center point for rotating the outer component 6122 of the outerring during retraction, as discussed in greater detail below. The wire6126 comprises a suitable material that is significantly harder than theouter component 6122 of the outer ring, for example full hard stainlesssteel. Some embodiments of the rigid wire of the inner componentcomprise a split wire 6126 having a first end and a second end. In someembodiments, the first and second ends of the rigid wire 6126 arecoupled together using any suitable method, for example, by at least oneof welding, using an adhesive, and/or using a mechanical fastener orcoupler.

As indicated above, the inner component of the outer ring may comprise agenerally circular rigid wire 6126. A diameter of the rigid wire 6126 isfrom between about 0.25 mm to about 12.7 mm (about 0.01 inch to about0.5 inch). The diameter of the wire 6126 varies with the wound sizeand/or the size of the retractor 6100. For example, a larger wound sizecorrelates with a larger wire diameter. In some embodiments, the wirediameter also correlates with the wire material. For example, increasinga hardness of the wire material permits reducing the wire diameter.

Some embodiments of the rigid wire 6126 for the inner component of theouter ring begin as a straight wire. The straight wire is inserted intothe middle lumen 6124 a of outer component. When the first and secondends of the outer component 6122 of the outer ring are joined, the wireassumes the desired shape, for example, a substantially circular shapeor an oval shape, placing the wire 6126 in a preloaded condition underwhich the wire 6126 has a tendency to straighten. The tendency of thewire 6126 to straighten out helps the outer ring 6120 to maintain thedesired shape, for example, circular or oval.

Some embodiments of the outer ring 6120 comprise a single, monolithiccoupler 6128 that couples the first and second ends of the outercomponent 6122 of the outer ring together, and that couples the firstand second ends of the wire 6126 of the inner component of the outerring together. Embodiments of the single, monolithic coupler comprise apolymer, plastic, or other suitable material. In some embodiments, themonolithic coupler comprises of at least one of a thermoplasticelastomer (HYTREL®, DuPont; PELLETHANE®, Dow),acrylonitrile-butadiene-styrene (ABS), polyamide (NYLON®, DuPont),polyether block amide (PEBAX®, Arkema), and high density polyethylene(HDPE).

In some embodiments, the inner ring 6110 and the outer ring 6120independently have different footprint shapes and/or footprintdiameters. An inner ring 6110 with a larger diameter permits a greaterretraction force, but is more difficult to insert and remove from a bodycavity. An outer ring 6120 with a larger diameter is easier to roll orrotate when retracting, but couple with a larger cap, and consequently,may not be useable in space constrained procedures. Oval or elongatedinner rings 6110 and outer rings 6120 reduce the force required toretract long, straight incisions compared with circular versions.

Some embodiments of the outer ring 6120 further comprise one or twosplit hoops disposed in one or both of the top lumen 6124 b and thebottom lumen 6124 c. Split hoops are discussed in greater detail below.

In some embodiments, the inner ring 6110 comprises a material that issofter than the material of the outer component 6122 of the outer ring.In other embodiments, the inner ring 6110 comprises a material of aboutthe same hardness as the material of outer component 6122 of the outerring, or harder than the material of the outer component 6122 of theouter ring.

FIG. 7 illustrates a partial side cross section of another embodiment ofa retractor 7100 generally similar to the embodiment 6100 describedabove. The retractor 7100 comprises an inner ring 7110, an outer ring7120, and a sleeve 7130 extending between and coupling the inner ring7110 and the outer ring 7120. In the illustrated embodiment, the outerring 7120 of the wound retractor includes an outer component 7122 havinga substantially oval cross-section including a first lumen 7124 a and asecond lumen 7124 b. Each of the first 7124 a and second 7124 b lumensis positioned substantially along the major axis of the oval crosssection with the first lumen 7124 a positioned on a first side of theminor axis of the oval and the second lumen 7124 b positioned on asecond, opposite side of the minor axis of the oval. The inner componentof the outer ring 7120 of the wound retractor includes a first splithoop 7126 a disposed in the first lumen 7124 a of the outer component ofthe outer ring, and a second split hoop 7126 b disposed in the secondlumen 7124 b of the outer component. In some embodiments, each of thefirst 7126 a and second 7126 b split hoops independently comprises ahoop having a single split about its periphery with the split creating afirst end of the split hoop and a second end of the split hoop. In itsneutral position, the first and second ends of the respective splithoops substantially abut each other. In some embodiments, the splithoops 7126 are substantially noncompliant under the conditions in whichthe retractor 7100 is used, for example, as compared to tissues of abody wall under retraction, the outer component 7122 of the outer ring,and the sleeve 7120.

In some embodiments, properties of the retractor 7100 including theretraction force applied by the retractor 7100 and the ease ofretracting an opening in a body wall depends at least in part on aspacing between the first 7124 a and second 7124 b lumens of the outercomponent of the outer ring, and a cross-sectional size or diameter ofthe first 7126 a and second 7126 b split hoops of the inner component ofthe outer ring. During use, the outer ring 7120 of the wound retractoris rolled down the sleeve 7130, thereby placing the split hoop 7126proximal to the user under tension, opening the split hoop 7126 bycreating a space between the first and second ends of the hoop 7124. Incontrast, the rolling places the split hoop 7126 distal to the userunder compression, forcing the first and second ends thereof together.In this manner, the rigid split hoop 7124 distal to the user serves asan axle or center of rotation for the outer ring 7120. Either or bothincreasing a distance between the two split hoops 7126 further apart, orincreasing the strength of the split hoops 7126, increases the forceused in rolling or rotating the outer ring 7120 of the wound retractor.Accordingly, the spacing or distance between the first 7124 a and second7124 b lumens, and the cross-sectional sizes or diameters of the first7126 a and second 7126 b split hoops are selected to balance the forcefor rotating the outer ring 7120 when retracting a body wall against thetendency of the outer ring to unroll 7120 under the force applied to theouter ring by the retracted body wall.

In some embodiments, the first 7126 a and second 7126 b split comprise ametal, for example, full-hard temper wire, stainless steel, piano wireheat treated to a spring temper, or any other suitable metal thatproduces a substantially noncompliant hoop. In some embodiments, thefirst 7126 a and second 7126 b split hoops comprise a rigid polymericmaterial fabricated by any suitable material, for example, by molding,machining, and/or and other suitable process known in the art. Thesubstantially noncompliant split hoops 7126 may also comprise any othersuitable rigid material known in the art.

In some embodiments, the cross-sectional diameters of the first 7126 aand second 7126 b split hoops vary with the cross-sectional dimensionsof the outer component 7122 of the outer ring, and with the size anddimensions of the incision or body opening to be retracted. In someembodiments, a wire diameter of from about 2.5 mm to about 3.5 mm, forexample, about 3 mm is used in retracting incisions of from about 5 cmto about 9 cm long. In some embodiments, each of the first 7126 a andsecond 7126 b hoops independently comprises a wire of from about 0.25 mmto about 6.35 mm (from about 0.01 inch to about 0.25 inch) in diameter.

The first 7126 a and second 7126 b split hoops of the inner component ofthe outer ring have smaller diameters in their relaxed states than thefirst lumen 7124 a and the second lumen 7124 b in which each isrespectively disposed. Accordingly, when the outer ring 7120 is in arelaxed state, each of the split hoops 7126 is under tension, while theouter component 7122 is under compression. Consequently, in someembodiments, the split hoops 7126 hold the outer component 7122 of theouter ring in a closed configuration. In some embodiments, thecompressive force of the first 7126 a and second 7126 b split hoops alsocontrol the orientation of the outer component 7122 in the relaxedstate: that is, with the split hoops 7126 substantially one above theother, and/or with the major axis of the cross section of the outercomponent 7122 substantially parallel to a longitudinal axis of theouter component 7122.

In some embodiments, each split hoop 7126 is fabricated as a circle orother desired shape with the first and second end portions thereofoverlapping each other. In some embodiments, dimensions of the firstlumen and the second lumen 7124 b and the composition of outer component7122 of the outer ring constrain the first and second end portions ofeach split hoop from overlapping each other when the first split hoop7126 a and second split hoop 7126 b are respectively disposed therein.In some embodiments, the lumens 7124 are dimensioned such that the firstand second ends of each split hoop 7126 substantially abut each otherwhen disposed therein. Other embodiments comprise a slight gap betweenthe first and second ends of at least one split hoop 7126 disposed inthe lumen 7124. The compressive spring force from the expanded splithoops urges the outer component 7122 to remain in a closed shape.Because the split hoops 7126 are disposed on either side of the minoraxis of the cross section of the outer component 7122, the first 7126 aand second 7126 b split hoops urge and maintain the configuration of theouter ring 7120 such that the major axis of the cross section of theouter component 7122 remains vertical at 0° and 180° orientations,thereby facilitating the attachment of the cap to the outer ring 7120 ofthe wound retractor, as discussed below. In some embodiments, the outerring 7120 is designed with an orientational bias other than vertical,for example, by changing at least one of the relative positions of thelumens 7124, the relative diameters of the lumens 7124, the relativerelaxed diameters of the split hoops 7126, the relative cross-sectionaldiameters of the split hoops 7126, and the relative compositions of thesplit hoops 7126.

Because each of the first 7126 a and second 7126 b split hoops hassubstantially abutting first and second ends when the outer ring 7120 isin a relaxed configuration, each of the split hoops 7126 successivelyfunctions as an axle about which the outer component 7122 undergoes ahalf or 180° rotation in the retraction process. More particularly, asthe outer ring 7120 is rolled, the first split hoop 7126 a, which isinitially above the second split hoop 7126 b, is rolled or rotatedaround and outside the second split hoop 7126 b, which serves as an axleor axis for the rotation, with the periphery of the first split hoop7126 a expanding to clear and pass around the second split hoop 7126 b,resulting in the first split hoop 7126 a below the second split hoop7126 b. On continued rolling of the outer ring 7120, the roles of thefirst 7126 a and second 7126 b split hoops are reversed, with the secondsplit hoop 7126 b rolling around and outside the first split hoop 7126 awith the periphery of the second split hoop 7126 b expanding to clearand pass around the first split hoop 7126 a, which serves as an axle forthe rotation. These steps are repeated until the incision or bodyopening is retracted to the desired degree.

In some embodiments, the outer ring 7120 of the wound retractorcomprises an extruded elastomeric tube with a desired shape, forexample, a generally circular or oval ring. In some embodiments, thefirst 7126 a and second 7126 b split hoops disposed in the first 7124 aand second 7124 b lumens of the outer component 7122, respectively,serves as a framework or scaffolding for the outer ring 7120, andconsequently, determine the general shape thereof. In some embodiments,one of the first and second ends of the first split hoop 7126 a isinserted into the first lumen 7124 a of outer component, and one of thefirst and second ends of the second split hoop 7126 b is inserted intothe second lumen 7124 b of the outer component. Each of the first 7126 aand second 7126 b split hoops is continually fed into its respectivelumens 7124 until each of the split hoops 7126 is substantially entirelywithin its respective lumen 7124. The outer component 7122 generallyassumes the shape of the split hoops 7126 positioned in the first 7124 aand second 7124 b lumens thereof. Some embodiments further comprise acoupler disposed between the first and second ends of the outercomponent 7122.

Referring again to the outer component 7122 of the outer ring, a ratiobetween a cross-sectional height and cross-sectional width thereofcreates lock points as the outer component 7122 is rotated around theinner component. As the sleeve 7230 rolls-up around the outer ring 7120when rotating the outer ring 7120, the lock points reduce or prevent theouter ring 7120 from rotating backwards, thus prevent the sleeve 7230from unraveling or unrolling from the outer ring 7120. These lock pointsalso provide incremental rotational positions for the outer ring 7120,thereby providing incremental retraction of the wound. Generallysymmetrical cross-sectional shapes provide substantially uniformrotational motion and lock points, thereby providing a substantiallyuniform “snap” feel with each incremental rotation. The lock points alsohelp keep the first, outer component of the second, outer ring fromtilting as a result of forces encountered when retracting the surgicalincision or body orifice. The illustrated embodiment comprises lockpoints where the cross-sectional major axis of the outer component 7120is generally vertical, parallel to the longitudinal axis of the outercomponent 7120, or at 0° and 180°.

As stated above, embodiments of the outer component 7120 comprise athermoplastic elastomeric material, such as HYTREL® (DuPont) orPELLETHANE® (Dow). Increasing the hardness of the material of the outercomponent 7122 increases the force used to rotate the outer ring 7120,as well as the resistance to unlock the outer ring 7120 from each lockpoint with each rotation of the outer ring 7120. Accordingly, thehardness of the material of the outer component 7122 in conjunction withthe cross-sectional height and width of the outer component 7122 areselected to provide suitable or sufficient lock points for the outerring 7120. For example, increasing the cross-sectional height-to-widthratio of the outer component 7122 permits reducing the material hardnesswhile providing similar lock-point resistance or “snap”. Conversely,increasing the material hardness permits reducing the cross-sectionalheight-to-width ratio of the outer component 7122.

Embodiments of the footprint of the outer ring 7120 are symmetrical ornon-symmetrical and can vary in size and shape, such as a circle,ellipse, oval, or any other suitable shape, to conform to a body type,position, or size, thereby increasing or improving working space, orreducing potential interference with other instruments or ports during alaparoscopic procedure.

Reducing the cross-sectional profile or dimension of the outer ring 7120of the wound retractor increases a range of insertion angles forinstruments inserted therethrough. More particularly, one or both of thecross-sectional height and width of the outer ring 7120 may be reduced.The increased insertion-angle range is particularly useful for bodyorifice retraction, such as rectal or vaginal retraction. Reducing thecross-sectional profile of the outer ring 7120 increases the difficultyof rolling or rotating the outer component 7122 of the outer ring aboutthe inner component of the outer ring 7120 during retraction.Accordingly, in some embodiments, a suitable tool used to facilitaterolling the outer component 7122 about the inner component.

An embodiment of a procedure for retracting an incision or body orificeis described with reference to the embodiment of the retractor 6100illustrated in FIG. 6A, although the procedure is applicable to all ofthe embodiments of the retractor disclosed herein. In use, the surgicalwound retractor 6100 is inserted into an incision, such as an incisionmade in an abdominal wall (FIG. 1), or a body orifice, such as thevagina (FIG. 2), mouth (FIG. 3) or anus (FIG. 4). The inner ring 6110 isfolded or compressed into an oval or other suitable shape and urgedthrough the incision or body orifice into an associated body cavity.Once the inner ring 6110 is fully disposed within the associated bodycavity, it is allowed to resume its original, relaxed shape, forexample, substantially circular, oval, or other original shape. Theinner ring 6110 is then pulled upward against the inner surface of thebody cavity, for example, by pulling the outer ring 6120 upward.

When the inner ring 6110 is fully in place, the outer ring 6120 isrotated rolled about its annular axis, which is defined by the innercomponent thereof. As discussed above, in the rolling procedure, theportion of the outer component 6122 distal from the user moves passesthrough the interior of the annular axis in moving towards the user,while the portion of the outer component 6122 proximal to the userpasses around the exterior of the annular axis in moving away from theuser. Rolling the outer ring 6120 rolls the sleeve 6130 around the outerring 6120, reducing the distance between the inner ring 6110 and theouter ring 6120 and tensioning the sleeve 6130 therebetween, therebyretracting the incision or body orifice.

The outer ring 6120 is rolled until a desired state or degree ofretraction is attained with the outer ring 6120, with a portion of thesleeve wrapped therearound, substantially in contact with the exteriorsurface of the body wall. When the outer ring 6120 and portion of thesleeve wrapped therearound is in contact with the exterior surface ofthe body wall, the outer ring 6120 of the retractor is sufficientlyrigid to maintain the desired state or degree of retraction of theincision or body opening, for example, substantially fully retracted. Issome embodiments, the incision or body opening is not fully retracted,and is, instead, only partially retracted, which permits a degree ofmotion for the retractor 6100 associated cover 5500 (FIG. 5) relative tothe incision or opening. Moreover, when the outer ring 6120 with aportion of the sleeve wrapped therearound is in contact with theexterior surface of the body wall, the outer ring 6120 of the woundretractor is noncompliant, that is, not flexible or likely to yieldunder the forces normally experienced during use of the wound retractor6100. Accordingly, embodiments of the rigid outer ring 6120 facilitate360° atraumatic retraction of an incision or body opening. Theillustrated wound retractor 6100 is a durable device that providesreliable protection of the incision or body opening during surgery.

As illustrated in FIG. 5, some embodiments of the access device 5000comprise a cap, cover, or lid 5500 coupled to the outer ring of theretractor 5100, which seals the retractor 5100, for example, formaintaining pneumoperitoneum. In some embodiments, lid 5500 isremovable, for example to provide access into the body cavity. Someembodiments of the lid 5500 comprise a transparent or translucentportion, thereby allowing a user to view into the body cavity withoutremoving the lid 5500. As will be described below, one embodiment of alid 5500 is a gel cap. In some embodiments, a cross-sectional shape ofthe outer component 6112 (FIG. 6A) of the outer ring of the woundretractor is selected to reduce or prevent the lid 5500 from partialand/or incorrect coupling to the outer ring 6110 (FIG. 6A) of the woundretractor. Such cross-sectional shapes include oval and rectangular, orany other suitable cross-sectional shape that provides the desiredfunctionality, for example, hexagonal, octagonal, and the like.Additionally, depending on the use and on surgeon preference, in someembodiments, each of the inner ring 6110 and outer ring 6120 of thewound retractor includes independently variable design configurations.For example, embodiments of the inner ring 6110 and/or the outer ring6120 are rigid or flexible, and have footprints, cross-sectional shapes,and/or dimensions dependent on the intended use, for example, circularor oval footprints, diameters dependent on incision or orificedimensions, or cross-sectional dimensions dependent on retraction force.

Accordingly, embodiments of the wound retractor 6100 enable a surgeon toquickly retract and protectively line a surgical incision or naturalbody orifice, while easily accommodating variations in the body wallthicknesses between patients. In addition, embodiments of the device6100 effectively seal around the interior and exterior of the incisionor orifice, and allow a sealing cap 5500 (FIG. 5) to be coupled thereto,thereby effectively sealing the body cavity and enabling a surgicalprocedure to be performed.

FIG. 8A is a partial side cross-sectional view of another embodiment ofa retractor 8100 comprising an inner ring 8110, an outer ring 8120, anda flexible sleeve 8130. A tether 8140 comprises a distal end 8142secured to the inner ring 8110. A proximal end 8144 of the tetherextends through the sleeve 8130 and the outer ring 8120, terminating inan optional handle 8146 in the illustrated embodiment. As illustrated inFIG. 8B, in an embodiment of a method for removing the retractor 8100from a patient, pulling the handle 8146 of the tether draws the innerring 8110 towards the outer ring 8120. Further pulling the tether 8140causes the inner ring 8110 to contact the outer ring 8120, therebydeforming the inner ring 8110 as it passes through the outer ring 8120.Embodiments of tethers are also disclosed in U.S. Patent Publication No.2006/0149137 A1, the disclosure of which is incorporated by reference.

In some embodiments, the tether comprises a fiber, a woven cord, or abraided cord. In some embodiments, the tether 8140 comprises a tube. Insome embodiments, the tether 8140 comprises a cord and a tube, forexample, disposed within the tube, integrated within a wall of the tube,or secured to an outer wall of the tube. The tether 8140 comprises anysuitable material, for example, at least one of a suture material,polymer resin, polyamide (NYLON®, DACRON®), polyester, silk,polyethylene, polyether block amide (PEBAX®), and the like.

In some embodiments, the tether 8140 is releasably secured to an innerwall of the sleeve 8130 such that when the outer ring 8120 is rotatedabout its annular axis while retracting, the tether 8140 is releasedfrom an edge of the sleeve 8130 proximal to the outer ring 8120 as thesleeve 8130 winds therearound.

In some embodiments in which the tether 8140 comprises a tube, thetether further comprises at least one fluid opening through the wall ofthe tube disposed at or near the distal end 8142 thereof. In some ofthese embodiments, the tether 8140 is also useful as a gas inlet/outlet,for example, for an insufflation gas. In some procedures, the body wallcreates a constriction in the sleeve 8130 when the retractor 8100 is inuse. This constriction can restrict gas exchange and/or movement betweena volume below the constriction and a volume above the constriction. Inparticular, the fluid opening at the distal end 8142 of the tether isbelow the constriction, while a fluid opening disposed at or near theouter ring 8120 or cap or cover 5500 (FIG. 5) is above the constriction.Positioning the fluid opening in the tether 8140 below the constrictionfacilitates gas injection into and/or venting from the volume below theconstriction, and is particularly useful for venting vapors and/or smokefrom the body cavity, which are generated, for example, inelectrosurgical procedures such as cutting and cauterizing. In someembodiments, a fluid opening at the proximal end 8142 of the tubulartether extends through the gel cap and is fluidly connected to a gassource and/or vacuum source. In other embodiments, the fluid opening atthe proximal end 8142 of the tether is fluidly coupled to another gasfitting, for example, disposed on the interior of the gel cap.

FIG. 9A is a side view of an embodiment of an insertion tool 9700 forinserting an inner ring 9110 of a retractor 9100. The insertion toolcomprises an obturator 9710 and a cannula 9720. The obturator 9710comprises an elongate, cylindrical body 9712 comprising a proximal endand a distal end, a handle 9714 at the proximal end of the body 9712,and a hook 9716 at the distal end of the body. The cannula 9720comprises a tubular body 9722 comprising a proximal end and a distalend, and handle 9724 at the proximal end. The tubular body 9722 is openat both the proximal and distal ends, and is dimensioned to slidablyreceive the cylindrical body 9712 of the obturator therein. The tubularbody 9722 is also dimensioned to receive at least a portion of the innerring 9110 of a retractor. Other embodiments of insertion and extractiontools are described in U.S. Patent Publication No. 2006/0149137 A1, thedisclosure of which is incorporated by reference.

As illustrated in FIG. 9A, the inner ring 9110 is loaded into the distalend of the tubular body 9722 of the cannula, which is then insertedthrough an opening or incision 9752 in a body wall 9750. The distal endof the obturator 9710 is inserted into and advanced through the proximalend of the tubular body 9722, thereby urging the inner ring 9110 out ofthe tubular body 9722 and into the body cavity 9754.

FIG. 9B illustrates another embodiment of a method for inserting aninner ring 9110 into a body cavity 9754 through an opening 9752 withoutusing the cannula 9720. In this embodiment, a portion of the inner ring9110 is captured in the hook 9716 disposed at the distal end of theobturator. The distal end of the obturator 9710 and the captured innerring 9110 are urged through the opening 9752 and into the body cavity9754.

FIG. 9C illustrates an embodiment of a method for removing the innerring 9110 using the hook 9716 of the obturator. The distal end of theobturator 9710 is inserted through the opening 9752 in the body wallbetween the sleeve 9130 and the body wall 9750. After capturing theinner ring 9110 with the hook 9716, the obturator 9710 and inner ring9110 are withdrawn through the opening 9752.

FIG. 10A illustrates in perspective an embodiment of a cap or cover10500, which is a surgical access device that seals the opening betweenthe body cavity and the area outside the body cavity while providingaccess into the body cavity from outside the body cavity. Moreparticularly, the illustrated cap 10500 releasably and sealingly couplesto the outer ring 6120 (FIG. 6A) of the wound retractor. The cap 10500comprises a cap ring 10510 dimensioned and configured for coupling tothe outer ring 6120 of the wound retractor and a pad 10530 coupled tothe cap ring 10510. Embodiments of the cap 10500 provide an artificialbody wall with consistent properties compared with a natural body wall,for example, thickness, compliance, rigidity, uniformity, and the like.

The illustrated cap or cover 10500 is substantially circular. In otherembodiment, the gel cap 10500 has another shape or footprint, forexample, oval, elliptical, parabolic, square, rectangular, or anothersuitable curved or polygonal shape. In some embodiments, the outer ring6120 of the retractor and cap ring 10510 of the cap have the samegeneral shape or footprint. In other embodiments, the outer ring 6120 ofthe retractor and cap ring 10501 of the cap have substantially differentshapes, for example, a generally circular outer ring 6120 and an ovalcap ring 10510. In these embodiments, the outer ring 6120 is distortedor reshaped for coupling to the cap ring 10510, for example, bycompressing opposed sides of the outer ring 6120. Non-circular shapesare useful, for example, for procedures in which space is limited. Asdiscussed above, retracting a long, straight incision using an oval orelongated retractor requires less force than a similar procedure using acircular retractor.

In some embodiments, the pad 10530 comprises a gel. In such embodiments,the pad 10530 is referred to as a “gel pad” and the cap 10500 isreferred to as a “gel cap”. Descriptions of gel pads and gel capsgenerally apply to embodiments in which the pad 10530 does not comprisegel unless otherwise specified. In some embodiments, the gel pad 10530does not comprise any preformed access channels therethrough, forexample, for instrument access. Instruments may be inserted directlythrough the gel pad 10530, puncturing the gel pad 10530, and therebycreating access channels or portions in the gel pad 10530. Each accessportion forms an instrument seal in the presence of an instrumentinserted therethrough and a zero seal in the absence of an instrumentinserted therethrough. The gel provides a gas tight seal around avariety of shapes and sizes of instruments inserted therethrough. Someembodiments of the gel pad 10530 also provide trocar access directlytherethrough, which also provide instrument access into the body cavity.Embodiments of the gel pad 10530 have a working diameter of from about40 mm to about 120 mm, which is the diameter of a portion of the gel pad10530 through which instruments and/or trocars may be inserted.Embodiments of the gel cap 10500 are typically from about 10 mm to 50 mmwider than the working diameter.

Accordingly, embodiments of the gel cap 10500 maintain pneumoperitoneumduring multiple instrument exchanges and substantially preventunintentional loss of pneumoperitoneum. Embodiments of the gel cap 10500also provide substantially continuous access and visibility duringsurgery. Embodiments of the gel cap 10500 have a small profile for usein procedures with limited surgical space.

In some embodiments, the gel is an ultragel, which is characterized byan ultimate elongation greater than about 1000 percent and a durometerless than about 5 Shore A. Some embodiments of the ultragel comprisingKRATON® and mineral oil exhibit an ultimate elongation exceeding about1500 percent and improved sealing properties, for example, sealing withinstruments of a wider size range than other seal materials. In someembodiments, the seals comprising ultragels also form zero seals whenthe instrument is removed therefrom. Accordingly, in some embodiments ofseals comprising ultragels, a single seal is acts as both the instrumentseal as well as the zero seal.

Some embodiments of the cap ring 10510 comprise a substantiallycylindrical ring comprising a proximal portion, a distal portion, and alongitudinal axis extending from the proximal portion to distalportions. In other embodiments, the cap ring 10510 has another shape orfootprint, for example, oval. As best seen in FIG. 10B, which is abottom view of a cap ring 10510, in the illustrated embodiment, theproximal portion of the cap ring 10510 comprises a plurality ofapertures 10512 distributed about the periphery thereof. The apertures10512 extend through a wall 10514 at the proximal portion of the capring. In other embodiments, the apertures 10512 are disposed in at leastone member extending either longitudinally inward or longitudinallyoutward from the wall 10514 of the cap ring. The gel pad 10530 isdisposed at the proximal portion of the cap ring 10510 in theillustrated embodiment, with portions of the gel pad 10530 extendingthrough the apertures 10512, thereby creating an interlocking structurebetween the cap ring 10510 and the gel pad 10530, mechanically lockingthe cap ring 10510 and the gel pad 10530 together.

The distal portion of the cap ring 10510 is substantially cylindrical inthe illustrated embodiment, and is dimensioned and configured to receivethe outer ring 6120 (FIG. 6A) of the wound retractor. The cap ring 10510comprises a latch mechanism 10516 that removably couples the cap ring10510 to the outer ring 6120. Those skilled in the art will understandthat other mechanisms are also useful for coupling the cap ring 10510 tothe outer ring 6120 of the wound retractor, for example, protrudinglips, levers, clips, latches, tongues, grooves, screw threads, bayonetmounts, screws, friction fittings, compression fitting, snap caps, andthe like. In the illustrated embodiment, when the outer ring 6120 of thewound retractor is received in the distal portion of the cap ring 10510,the outer ring 6120 of the wound retractor contacts and embeds within aportion of the gel pad 10530 disposed at the distal portion of the capring 10510, thereby displacing a portion of the gel, and forming a sealbetween the gel pad 10530, and the outer ring 6120 and sleeve 6130 ofthe wound retractor. Thus, the distal portion of the gel pad 10530 is injuxtaposition with the incision or body orifice. In other embodiments,the cap ring 10510 is permanently coupled or fixed to the outer ring6120.

The cap ring 10510 in some embodiments comprises a polymer. Examples ofsuitable polymers include, at least one of polyethylene (PE), lowdensity polyethylene (LDPE), high density polyethylene (HDPE), ultrahigh molecular weight polyethylene (UHMWPE), polycarbonate,thermoplastic elastomers (DYNAFLEX®, GLS Corp.; KRATON®, KratonPolymers), polyphenylene oxide (PPO), polystyrene, and the like. Thepolymer component of the cap ring is fabricated by any suitable method,including injection molding, melt casting, blow molding, and the like.

Some embodiments of a process in which the gel pad 10530 is cast in thecap ring 10510 are include steps performed at temperatures above about130° C. over several hours, for example, from about three (3) to aboutfour (4) hours. Accordingly, in some of these embodiments, the cap ring10510 does not deform under these conditions.

Some embodiments of the gel pad 10530 comprise an elastomeric gel.Examples of such gels are described in U.S. patent application Ser. No.10/381,220, filed Mar. 20, 2003, the disclosure of which is herebyincorporated by reference as if set forth in full herein. Embodiments ofthe gel are prepared by mixing at least one triblock copolymer with asolvent that dissolves the midblocks of the triblock copolymer. Themixture is typically a slurry. The endblocks typically comprise athermoplastic material, such as styrene, while the midblocks typicallycomprise a thermoset elastomer such as, ethylene/butylene, isoprene, orbutadiene. Examples of the triblock copolymer includestyrene-ethylene/butylene-styrene (SEBS), styrene-isoprene-styrene(SIS), and styrene-butadiene-styrene (SBS). In some embodiments, thesolvent is an oil, for example, mineral oil. Upon heating a mixture orslurry of the triblock copolymer, the midblocks dissolve in the mineraloil, thereby forming a network of the insoluble endblocks. The resultingnetwork has enhanced elastomeric properties compared with the parentcopolymer. In some embodiments, the triblock copolymer used is KRATON®G1651, which has a styrene to rubber ratio of 33/67. Once formed, thegel is substantially permanent and, by the nature of the endblocks,processable as a thermoplastic elastomer henceforward. The mixture orslurry has a minimum temperature at which it becomes a gel, which isreferred to as the minimum gelling temperature (MGT). This temperaturetypically corresponds to the glass transition temperature of thethermoplastic endblock plus a few degrees. For example, the MGT for amixture of KRATON® G1651 and mineral oil is about 120° C. When theslurry reaches the MGT and the transformation to a gel state takesplace, the gel becomes more transparent, thereby providing a visualendpoint confirming the complete transformation of the slurry to the gelstate, whereupon the gel may be cooled. Some embodiments of the gelcomprise a diblock copolymer, either instead of or in addition to thetriblock copolymer. Embodiments of the diblock copolymer comprise athermoplastic first endblock, for example, styrene, and a thermosetelastomeric second endblock, for example, ethylene/butylene, isoprene,or butadiene. An example of a suitable diblock copolymer isstyrene-ethylene/butylene (SEB).

For a given mass of slurry to form a complete gel, the entire mass ofthe slurry is heated to or above the MGT and held at or above the MGTfor a sufficient time for the end blocks to form a network or matrix ofinterconnections. The slurry will continue to form a gel at temperaturesbetween the MGT and temperatures at which the components of theslurry/gel begin to decompose and/or oxidize. For example, when theslurry/gel is heated at temperatures above 250° C., the mineral oil inthe slurry/gel will begin to be volatile and oxidize. Oxidizing maycause the gel to turn brown and become oily.

The speed at which a given volume of slurry forms a gel depends on thespeed with which the entire mass of slurry reaches the MGT. Also, attemperatures higher than the MGT, the end block networks distribute andform more rapidly, thereby speeding the gel formation.

The various base gel formulas may also be mixed or alloyed with oneanother to provide gels with a variety of intermediate properties. Forexample, KRATON® G1701X is a mixture of seventy percent (70%) SEB andthirty percent (30%) SEBS, with an overall styrene to rubber ratio of28/72. Those skilled in the art will appreciate that an almost unlimitednumber of combinations, alloys, and styrene to rubber ratios can beformulated, each providing and embodiment exhibiting one or moreadvantages, for example, low durometer, high elongation, and good tearstrength.

Some embodiments of the gel material further comprise a polymer that,with a foaming agent, improves the sealing properties of the gel, forexample, silicone, soft urethanes, and even harder plastics. Examples ofsuitable silicones include those used for electronic encapsulation.Examples of suitable harder plastics include polyvinylchloride (PVC),isoprene, KRATON® neat, and other KRATON®/oil mixtures. In theKRATON®/oil mixture, suitable oils include vegetable oils, petroleumoils, and silicone oils, as well as mineral oil.

Some embodiments of the gel comprise one or more additives that provideone or more desirable properties, for example, at least one of enhancedlubricity, improved appearance, and wound protection. Additives areincorporated directly into the gel and/or applied as a surfacetreatment. In some embodiments, other compounds are added to the gel tomodify its physical properties and/or to assist in subsequentmodification of the surface by providing bonding sites and/or surfacecharges. Additionally, oil-based colorants are added to the slurry tocreate gels of different colors in some embodiments.

Some embodiments of the gel pad 10530 comprise a layer of polyethyleneon at least one surface. Polyethylene is dissolved in mineral oil andthe solution applied to one or more surfaces of the gel pad 10530. Themineral oil does not evaporate, but instead, absorbs into the gel padover time, leaving behind the polyethylene as a layer on the surface ofthe gel pad.

In some embodiments, the triblock copolymer/solvent mixture/slurry usedto manufacture the gel pad 10530 comprises about ninety percent (90%) byweight of mineral oil and about ten percent (10%) by weight of KRATON®G1651. From a thermodynamic standpoint, this mixture behaves similarlyto mineral oil. Because mineral oil has a relatively high heat capacity,transforming 0.45 kg (1 pound) of the slurry into a homogenous gel atabout 130° C. may take from bout three (3) to about four (4) hours. Onceformed, the gel can be cooled as quickly as practicable with no apparentdeleterious effects on the gel. In some embodiments, the gel is cooledby cold-water immersion. In other embodiments, the gel is air-cooled.Those skilled in the art will recognize that other cooling techniquesare used in other embodiments.

Certain properties of the KRATON®/oil gel will vary with the weightratio of the components. In general, a higher proportion of mineral oilresults in a softer gel, while a higher proportion of KRATON® results ina firmer gel. A too-soft gel exhibits excessive tenting or doming of thegel cap 10500 during surgery when a patient's body cavity isinsufflated. Some embodiments of gels that are too soft also do providean adequate instrument seal and/or zero seal. The gel should besufficiently soft to provide an adequate seal both in the presence of aninstrument and in the absence of an instrument, however.

On prolonged or extended sitting or standing, the copolymer, such asKRATON®, and the solvent, such as mineral oil, in the slurry mayseparate. The slurry may be mixed to greater homogeneity, for example,with a high shear mixer. Mixing the slurry may introduce or add air tothe slurry, however. To remove air from the slurry, the slurry may bedegassed. In some embodiments, the slurry is degassed under a vacuum,for example, within a vacuum chamber. In some embodiments, the appliedvacuum is about 0.79 meters (about 29.9 inches) of mercury, or about one(1) atmosphere. Optionally, stirring or mixing the slurry under vacuumfacilitates removal of the air. During degassing under vacuum, theslurry typically expands, then bubbles, and then reduces in volume. Thevacuum is typically discontinued when the bubbling substantially ceases.Degassing the slurry in a vacuum chamber reduces the volume of theslurry by about ten percent (10%). Degassing the slurry also reducesoxidation of the finished gel in some embodiments.

Degassing the slurry tends to result in a firmer gel. A gel made from adegassed slurry comprising about 91.6% by weight of mineral oil andabout 8.4% by weight of KRATON® G1651, an eleven-to-one ratio, has aboutthe same firmness as a gel made from a slurry that is not degassed andthat comprises about ninety percent (90%) by weight of mineral oil andabout ten percent (10%) by weight of KRATON®G1651, a nine-to-one ratio.

Because mineral oil typically has a lower density than KRATON®, the twocomponents will separate after mixing, with the less dense mineral oilrising to the top of the container. This phase separation typicallyoccurs when transforming a static slurry into a gel over several hours.Consequently, the resulting gel is non-homogeneous, with a higherconcentration of mineral oil at the top and a lower concentration at thebottom. The speed of separation is a function of the depth or headheight of the slurry being heated. Factors relevant to the relativehomogeneity of the gel include the mass of slurry, the head height, thetemperature at which the gel sets, and the speed at which the energy istransferred to the gel.

The gel pad 10530 or gel cap 10500 are gamma sterilized in someembodiments, which is relatively and/or comparatively simpler to qualifycompared with other sterilization process, for example, versus ethyleneoxide. Gamma sterilization can cause large bubbles to form in the gelpad, however, which are cosmetic and/or aesthetic issues in thesterilized devices. Because bubbles typically comprise greater thanninety-nine percent (99%) room air, the dissolved air is advantageouslyremoved from the slurry prior to transforming the slurry into a gel. Forexample, the slurry may be degassed under vacuum, as described above,then gelled by heating. Some bubbles may still form in the gel duringgamma sterilization, but typically disappear over a period of from abouttwenty-four (24) hours to about seventy-two (72) hours. Typically,mineral oil at room temperature has about ten percent (10%) dissolvedgas. As discussed above, removing air from the gel makes the gel firmer.This effect is counterbalanced by a softening of the gel by the gammaradiation during gamma sterilization, however.

In some embodiments in which the gel pad 10530 is gamma sterilized, thegel comprises about ninety percent (90%) mineral oil by weight and aboutten percent (10%) KRATON® by weight. As stated above, degassing theslurry makes the gel firmer. The counteracting softening by the gammaradiation, however, results in a gel with substantially the samefirmness as a gel comprising about ninety percent (90%) mineral oil byweight and about ten percent (10%) KRATON® by weight that is notdegassed and gamma sterilized.

In some embodiments, the gel pad 10530 is coupled to, attached to,formed with, or integrated with the cap ring 10510 to provide agas-tight seal between the cap ring 10510 and the sleeve 6130 (FIG. 6A).The gel pad 10530 covers and seals the entire opening in the cap ring10510, as well as covering substantially the entire wound or orificeopening. As stated above, the gel pad 10530 provides a gas tight sealaround a variety of shapes and sizes of instruments insertedtherethrough.

Embodiments in which a gel pad support structure of the cap ring 10510comprises a thermoplastic elastomer, for example, DYNAFLEX® or KRATON®,and the gel pad 10530 comprises a similar thermoplastic elastomer, forexample, KRATON®, exhibit improved adhesion between the gel pad 10530and the cap ring 10510. The polystyrene component of KRATON® in the gelpad 10530 improves adhesion with polyphenylene oxide (PPO), polystyrene,and other similar polymers.

In some embodiments of cap rings 10510 comprising polycarbonate, thepolycarbonate component of the cap ring 10510 does not bond with the gelpad 10530 at 130° C., which is a typical manufacturing temperature for agel pad 10530 comprising KRATON®. Raising the temperature to about 150°C. for a few minutes during casting, however, bonds the gel pad 10530 tothe cap ring 10510. It is believed that heating the gel pad 10530 andcap ring 10510 to a temperature at which both the polystyrene componentof the gel and the polycarbonate are simultaneously above their meltpoints allows bonds to form therebetween. In other embodiments, theuncured gel and the cap ring 10510 are heated to near or at the glasstransition temperature of the polycarbonate in the cap ring 10510,thereby bonding the gel pad 10530 to the cap ring 10510.

In some embodiments, the gel comprises mineral oil and the cap ring10510 comprises a polymer that dissolves in mineral oil under themanufacturing conditions, for example, polyethylene (PE), low densitypolyethylene (LDPE), high density polyethylene (HDPE), and ultra highmolecular weight polyethylene (UHMWPE). Using polyethylene (PE) as anexample, PE has a higher molecular weight than mineral oil and dissolvesin mineral oil at the temperatures used to cast the gel pad 10530. Assuch, as a portion of the PE in the cap ring 10510 dissolves in themineral oil in the gel pad 10530 at the processing temperatures, forexample, above about 130° C., a bond between the PE in the cap ring10510 and gel pad 10530 is formed.

In an embodiment of a method for manufacturing a gel cap, the cap ring10510 is placed into a mold that together with the cap ring 10510includes a negative space in the desired shape of the gel pad anduncured gel is added to the mold. Sufficient uncured gel is then addedto the mold to cover and fill the apertures 10512. The uncured gel flowsthrough, fills, and remains within the apertures. Also, in someembodiments, the mold is filled with sufficient uncured gel to extendinto the distal portion of the cap ring 10510. After the gel cures, thegel in the apertures connects and couples the gel on a first side ofeach aperture 10512 to the gel on a second side of the aperture, therebymechanically locking the gel pad 10530 to the cap ring 10510.

Some embodiments include another method for coupling the gel pad 10530to the cap ring 10510, either in addition to or instead of themechanical interlocking discussed above. Such methods are useful, forexample, for coupling separately formed gel pads or gel slugs 10530 andcap rings 10510. Some embodiments use a glue or adhesive to couple thegel pad 10530 to the cap ring 10510, for example, cyanoacrylate(SUPERGLUE® or KRAZY GLUE®). The glue is believed to bond to either therubber or the styrene component of the triblock copolymer with a bond isfrequently stronger than the gel material itself. Some embodiments usesolvent welding in which a solvent dissolves a plastic in the cap ring10510 and the polystyrene in the gel pad 10530. The solvent is appliedto the gel pad 10530 and cap ring 10510 by any suitable method, forexample, by spraying and/or by dipping. In effect, the solvent meltsboth the plastic of the cap ring 10510 as well as the polystyrene in thegel pad 10530, thereby forming a bond between the two, which remainsafter the solvent evaporates.

In an embodiment for manufacturing a gel cap 10500, the gel pad 10530 iscast into the cap ring 10510 to form the gel cap 10500. The cap ring10510 is positioned in or placed into a mold cavity of a casting mold.Embodiments of the mold cavity include support for the annular walls ofthe cap ring 10510. Embodiments of the mold comprise a material withsufficient heat dissipation properties, for example, at least one ofaluminum, copper, and brass. Those skilled in the art will recognizethat other mold materials with lower heat dissipation properties willproduce acceptable parts in some embodiments. Furthermore, someembodiments of the mold comprise active cooling elements, for examples,channels through which coolants are pumped.

The mold cavity and cap ring 10510 assembly is then filled with adesired amount of the triblock copolymer/mineral oil slurry such thatthe slurry contacts the cap ring 10510. In some embodiments, the slurryis preheated, for example, to about 52° C. (125° F.), which facilitatesa complete filling of the mold cavity by the slurry, thereby reducingthe probability of voids in the gel. Preheating the slurry to atemperature below the MGT reduces the viscosity of the slurry and allowsthe slurry to flow more easily. As stated above, some embodiments of theslurry are degassed in a vacuum before casting. In some embodiments, theslurry is also degassed after it is filled in the mold cavity to removeany air that may have been introduced during the filling of the moldcavity, as well as to facilitate flow of the slurry into voids in themold. The mold, cap ring, and slurry are heated, for example, in anoven, until the slurry reaches a temperature of about 150° C. As statedabove, the slurry turns into gel at about 120° C.; however, at about150° C., the gel bonds to a polycarbonate cap ring 10510. Depending onthe material used in the cap ring 10510, bonding may take place at atemperature other than about 150° C. In embodiments in which the capring 10510 is comprises a material with a lower melting point than theMGT, for example 120° C., the gel pad 10530 is molded separately as agel slug, which is then bonded to the cap ring 10510 as discussed above.

When the transformation of the slurry into a gel is complete, forexample, when the temperature of the gel pad reaches about 150° C., thegel cap 10500 is cooled, for example, by air-cooling, cold-waterimmersion, or another suitable method. At 150° C. the gel pad 10530 issoft and easily distorted. Distortions in the gel pad 10530 presentduring cooling would be set after cooling. Accordingly, in someembodiments, the gel cap 10500 is cooled within the mold, therebyreducing the likelihood of distorting the gel pad 10530. Factorsaffecting the cooling time include the size and configuration of themold, the quantity of gel, temperature and quantity of cooling medium,the properties of the cooling medium, and the mold material. As anexample, the cooling time for a particular gel cap 10500 may be abouttwo (2) hours for air cooling and about fifteen (15) minutes for watercooling. Whether cooling with air or water, the final properties of thegel are substantially the same. The gel cap 10500 is typically cooled toabout ambient room temperature, but may be cooled to a lower temperatureif desired. At about 0° C., the gel hardens, which is useful, forexample, in secondary operations such as when coupling separatelymanufactured gel pads 10530 and cap rings 10510. The gel cap 10500 maybe removed from the mold at any time after the gel has set.

When removed from the mold, the gel pad 10530 typically has a tackysurface. Coating the gel pad 10530 with a powder, such as cornstarch,substantially reduces or eliminates the tackiness of the cured gel pad10530.

As stated above, in some embodiments, the gel pad 10530 is moldedseparately from the cap ring 10510, and coupled to the cap ring 10510 ina secondary operation, for example, bonding. In some embodiments, thegel pad 10530 is molded as a gel slug with an outer perimeter smallerthan the perimeter of the inner cylindrical wall of the cap ring 10510and a height greater than the height of the cap ring 10510. Because thegel pad 10530 is molded separate from the cap ring 10510, the slurryneed only be heated to the MGT, for example, about 120° C., to completethe transformation of the slurry into a gel, whereupon the gel becomessubstantially transparent. As discussed above, the gel slug may becooled, for example, to about 0° C., then placed within the innercylindrical wall of the cap ring 10510.

In some embodiments, the gel slug is coupled to the cap ring 10510through compression molding, in which the gel slug is compressedlongitudinally, thereby expanding the outer perimeter of the gel slugand compressing the gel slug against the inner cylindrical wall of thecap ring 10510. The compressed gel slug and cap ring 10510 are thenheated to a sufficient temperature for the polystyrene in the gel andthe polymer of the cap ring 10510 to form bonds therebetween. Moldingthe gel slug separately from the cap ring 10510 followed by heat bondingthe gel slug to the cap ring is especially useful in embodiments inwhich the cap ring 10510 comprises a material with a melting temperaturelower than the MGT of the gel. In such situations, the gel slug can bemolded separately and heat bonded to the cap ring 10510 without meltingthe cap ring 10510.

A embodiment of a method for retracting an incision or body orificeusing the retractor 6100 is discussed in detail above. The methodresults in the outer ring 6120 of the retractor with a portion of thesleeve 6130 wrapped therearound substantially in contact with theexterior surface of the body wall. The gel cap 10510 is then coupled tothe outer ring 6120 of the wound retractor, thereby sealing the openingbetween the body cavity and the area outside the body cavity andallowing the surgeon to insufflate the body cavity.

As discussed above, embodiments of the gel cap 10500 comprise nopreformed access channels in the gel pad 10530. In use, instruments maybe inserted directly through the gel pad 10530, thereby creating accesschannels through the gel pad 10530. Each access channel created in thegel cap forms an instrument seal in the presence of an instrumentpassing therethrough because the gel provides a gas tight seal around avariety of shapes and sizes of instruments. When the instrument isremoved from the gel pad 10530, the channel created in the gel pad bythe instrument closes to form a zero seal.

Some embodiments of the gel pad 10530, however, are damaged by repeatedinsertion and removal of instruments through an access channel, forexample, exhibiting shredding, flaking, or the like. The damage candegrade the instrument seal or the zero seal of the affected accesschannel. Shreds or particles of the damaged gel can also fall into thebody cavity. Accordingly, some embodiments use access devices such astrocars inserted through the gel pad 10530 for instrument access, inparticular, where an access channel experiences repeated instrumentmanipulation, for example, insertion, removal, advancement, retraction,rotation and/or other manipulation. Each trocar inserted through the gelpad 10530 permits repeated introduction, removal, and/or manipulation ofinstruments therethrough without damaging the gel. Because the trocaritself is typically not extensively manipulated during a procedure, theaccess channel through which the trocar extends is not subject todamage, thereby maintaining the integrity of the gel pad 10530.Embodiments of the trocar are designed to withstand extensive instrumentmanipulation without failure under ordinary conditions.

Because the gel cap 10500 initially comprises no access channels, thesurgeon is at liberty to determine the placement of instrumentstherethrough. Moreover, the surgeon has unlimited flexibility in theplacement and repositioning of ports within the area of the gel cap10500, as well as the option of selecting different trocar sizes fordifferent clinical procedures. Being detachable, the gel cap 10500allows for the removal of large specimens. Once removed, the gel cap10500 can be re-coupled to the outer ring 6120 of the wound retractor,thereby restoring the seal and allow the surgeon to re-insufflate thebody cavity.

Moreover, embodiments of the gel are deformable without losing physicalintegrity, and while maintaining substantially gas tight instrumentseals with any instruments extending therethrough, as well as gas tightzero seals for any access channels without any instruments extendingtherethrough. Accordingly, embodiments of the gel cap 10500 permit bothtranslational or positional, and angular or pivotal “float” or degreesof freedom for the instruments passing through the gel pad 10530. Thisfloat permits instrument motion both relative to the cap ring 10510 aswell as relative to other instruments. In contrast, other single orlimited port systems do not exhibit one or both translational or angularfloat for instruments.

FIG. 11A is a top view of an embodiment of a gel cap 11500 comprising aplurality of access ports, seals, or sealing valves disposed in the gelpad. FIG. 11B is a perspective top view of the gel cap 11500 mounted ona retractor. FIG. 11C is a perspective bottom view of the gel cap 11500mounted on a retractor. The gel cap 11500 comprises a cap ring 11510 anda gel pad 11530, which are generally similar to the cap ring and gel padof the embodiment described above.

The gel cap 11500 further comprises a plurality of access ports 11540,at least a portion of which is disposed within or embedded within thegel pad 11530. In the illustrated embodiment, the access ports 11540have a low profile, that is, do not protrude or protrude minimally abovethe proximal surface of the gel pad 11530 and/or below the distalsurface of the gel pad 11530. Accordingly, the lengths of the accessports 11540 are similar to the thickness of the gel pad 11530, which isshorter than a length of a typical trocar inserted in the gel pad 11530,which comprises a seal assembly positioned above the gel pad 10530, anda cannula extending through the gel pad 11530. The reduced length of theaccess port 11540 allows increased angular or pivotal motion forinstruments extending therethrough, and also permits the use of curvedand/or angled instruments. In the illustrated embodiment, the accessports 11540 are substantially permanent or non-removable under theconditions under which the gel cap 11500 is used. Trocars can also beinserted through the gel pad 11530 if additional ports are desired.

Each port 11540 comprises longitudinal axis extending from a proximalside to a distal side of the gel pad 11530, a first seal 11542 disposedat the proximal side of the gel pad 11530, and a second seal 11544disposed distal to the first seal 11542. A sight of each of the ports orseals 11540 has an aperture through the gel pad 11530 and coincides withthe longitudinal axis. In the illustrated embodiment, the first seal11542 forms an instrument seal with an instrument extending therethroughand the second seal 11544 forms a zero seal in the absence of aninstrument extending therethrough.

In the illustrated embodiment, the first seal 11542 comprises a septumseal. Each septum seal comprises an aperture 11546 therethrough that isslightly smaller than a cross-section of the smallest instrument to beinserted therethrough. The aperture 11546 of the septum seal issubstantially aligned with the aperture through the gel pad and thelongitudinal axis of the port 11540. When an instrument is insertedthrough the aperture 11546 of the septum seal, the aperture 11546expands and engages the outer surface of the instrument, thereby forminga seal therewith. The septum seal comprises an elastomeric material thatbiases the aperture against an instrument is inserted therethrough.Those skilled in the art will understand that other types of instrumentseals are used in other embodiments.

In the illustrated embodiment, the second seal 11544 comprises adouble-duckbill valve, which functions as a zero-closure seal thatprovides a zero seal in the absence of an instrument insertedtherethrough. Those skilled in the art will understand that the secondseal comprises another type of seal, for example, a duckbill valve, aflap valve, and the like. The double-duckbill valve comprises aselastomeric material. In some embodiments, each of the first seal 11542and the second seal 11544 independently comprise an elastomericmaterial, for example, at least one of rubber, synthetic rubber,silicone, ethylene propylene diene monomer (EPDM), ethylene-propylenecopolymer (EP rubber), polyisoprene, polybutadiene, polyurethane,styrene-butadiene, ethylene vinyl acetate (EVA), polychloroprene(Neoprene®), perfluorelastomer (Kalrez®), and the like

Thus, during use, the septum seal provides an instrument seal in thepresence of an instrument inserted therethrough, and the duckbill valveprovides a zero seal in the absence of an instrument insertedtherethrough. The illustrated embodiment comprises ports or seals 11540in the gel pad of different sizes. Each size of port 11540 sealingaccommodates a different range of instrument sizes insertedtherethrough. The size of a port is typically given as the diameter ofthe largest instrument that the port will accommodate, for example, 5mm, 11 mm, or 12 mm. FIGS. 11D, 11E, and 11F are a perspective top view,a perspective bottom view, and a side view of a thinner instrument 11550a and a thicker instrument 11550 b inserted through a smaller port 11540a and a larger port 11540 b, respectively, of the embodiment of the gelcap 11500 illustrated in FIGS. 11A-11C.

FIG. 11G is a top perspective view of an embodiment of a gel cap 11500further comprising a fixed port position, for example, for a camera or alaparoscope. The fixed port 11560 comprises a lock mechanism 11562 thatmaintaining the position of a camera or laparoscope insertedtherethrough. In some embodiments, one of the ports 11540 furthercomprises a stopcock and/or gas fitting used as a gas inlet and/oroutlet port for insufflating, depressurizing, and/or venting the bodycavity of gas. In some embodiments, a gas inlet/outlet port is disposedon the cap ring 11510.

FIG. 12 is a cutaway perspective view of an embodiment of an accessdevice system 12000 comprising retractor 12100 and a cap or cover 12500,which are similar to embodiments of retractors and gel caps describedabove. The retractor 12100 comprises an inner ring 12110, an outer ring12120, and a sleeve 12130 extending between the inner ring 12110 and theouter ring 12120. In the illustrated embodiment, the cap 12500 is a gelcap comprising a proximal side, a distal side, a cap ring 12510, and agel pad 12530. In the illustrated embodiment, the cap ring 12510comprises a tubular ring dimensioned to receive the outer ring 12120 ofthe retractor therewithin. The distal side of the cap ring 12510comprises an annular slot 12520, which is sufficiently radiallydeformable for the outer ring 12120 to reversibly pass therethrough.Accordingly, the illustrated embodiment of the cap ring 12510 securesthe cap 12500 to the outer ring 12120 with a snap or friction fit.

FIG. 13 is an exploded view of an embodiment of a trocar 13800 andoptional obturator 13900, which is a component of some embodiments ofthe access device system. The trocar 13800 comprises a proximal end, adistal end, and a longitudinal axis. The trocar 13800 comprises acannula 13810 extending along the longitudinal axis. A trocar seal 13820is disposed at the proximal end of the cannula 13810. A retainer 13830is disposed at the distal end of the cannula 13810. The illustratedembodiment of the trocar 13800 does not comprise an insufflation gasinlet. Consequently, the trocar 13800 is typically used in procedures inwhich a body cavity is not insufflated, or in which insufflation isprovided through another device. Other embodiments of trocars aredisclosed in U.S. patent application Ser. No. 11/677,994, filed Feb. 22,2007, the disclosure of which is incorporated by reference.

The cannula 13810 is dimensioned to accommodate an instrument orinstruments received therethrough. In some embodiments, the cannula13810 is comparatively short because the cannula 13810 need onlytraverse the gel pad 10530 (FIG. 10) rather than a body wall.Accordingly, some embodiments of the cannula 13810 are not more thanabout 2-times longer, about 1.5-times longer, about 1.2-times longer, orabout 1.1-times longer than the thickness of the gel pad. In someembodiments, the cannula 13810 is less than about 20 mm, about 10 mm, orabout 5 mm longer than the thickness of the gel pad. In someembodiments, the cannula 13810 is about as long as the gel pad is thick.In other embodiments, the cannula 13810 has a different length, forexample, a length typical for a cannula used for traversing a body wall.Shorter length cannula permit increased angular degrees of freedom forinstruments passing therethrough. Embodiments of shorter cannula alsoaccommodate curved instruments. The cannula 13810 comprises any suitablebiocompatible material. In some embodiments, the cannula 13810 comprisesa flexible material.

The illustrated trocar seal 13820 comprises an instrument or septum seal13822 and a zero seal 13824. The instrument seal 13822 seals instrumentspassing therethrough, thereby maintaining pneumoperitoneum. The zeroseal 13824 provides a seal when no instrument passes through the trocarseal 13820. The instrument seal 13822 and zero seal 13824 are receivedin a housing 13826 disposed at the proximal end of the cannula 13810 andsecured therein by a seal cover 13828.

The retainer 13830 is disposed at or near the distal end of the cannula13810. In some embodiments, the retainer 13830 and cannula 13810 areintegrated, while in other embodiments, the retainer 13830 and cannula13810 are not integrated. In the illustrated embodiment, the proximalend of the retainer 13830 is generally flat and perpendicular to thelongitudinal axis, while the distal end is tapered, narrowing toward thedistal end of the cannula 13810. The flat, proximal end of the retainer13830 reduces the likelihood of accidental or inadvertent removal of thetrocar 13800 from the gel pad. The tapered end of the retainer 13830facilitates insertion of the trocar 13800 through the gel pad, either byitself, or when assembled with the obturator 13900 extendingtherethrough.

In some embodiments in which the retainer 13830 and cannula 13810 arenot integrated, that is, are separate components, the retainer 13830 issecured to the cannula 13810 after the cannula 13810 is inserted throughthe gel pad. In some embodiments, the cannula 13810 and retainer 13830are secured mechanically, for example, using latches, screw threads,clips, lock rings, ratchets, and the like. In some embodiments, thecannula 13810 and retainer 13830 are secured adhesively. In someembodiments, the position of the retainer 13830 is adjustable, forexample, to accommodate gel pads of different thicknesses. In someembodiments, the cannula 13810 and/or retainer 13830 is secured to thegel pad, for example, adhesively.

While certain embodiments have been particularly shown and describedwith reference to exemplary embodiments thereof, it will be understoodby those of ordinary skill in the art that various changes in form anddetails may be made therein without departing from the spirit and scopethereof as defined by the following claims.

1. A surgical access port adapted for performing laparoscopic surgicalprocedures at a single access site wherein an incision is made in theabdominal wall of a patient and the abdominal cavity is pressurized withan insufflation gas, the access port adapted to provide access to theabdominal cavity for surgical procedures while maintaining insufflationpressure in the abdominal cavity, the surgical access port comprising:an adjustable wound retractor comprising: a proximal ring, wherein theproximal ring is configured to be disposed proximate the outer surfaceof the abdominal wall of the patient and substantially surround theincision; a retraction sheath comprising a tubular wall, a proximalportion coupled to the proximal ring during use, and a distal portion,wherein the retraction sheath is configured to be disposed through theincision and line the incision, and wherein the retraction sheath isadjustable to retract the incision; and a distal ring coupled to thedistal portion of the retraction sheath, wherein the distal ring isconfigured to be disposed proximate the inner surface of the abdominalwall and substantially surround the incision; and a gel cap configuredto be coupled to the proximal ring, comprising: a cap ring, wherein thecap ring is configured to substantially surround the incision; a gel paddisposed within the cap ring; and a plurality of sealing valvesoperatively attached to the gel pad, wherein the plurality of sealingvalves have a low profile with an upper surface of each of the pluralityof sealing valves being disposed below or flushed with an upper surfaceof the gel pad, the upper surface of the gel pad being a single planarsurface, wherein the plurality of sealing valves at least partially forma plurality of access channels through the gel pad, and wherein theplurality of sealing valves are configured to form seals withinstruments extending through the sealing valves and form seals in theabsence of any instruments extending through the sealing valves and thesealing valves are made of a material different from the gel pad.
 2. Thesurgical access port of claim 1, wherein at least a portion of at leastone of the sealing valves defines an orifice.
 3. The surgical accessport of claim 1, wherein at least a portion of at least one of thesealing valves comprises a septum seal being made of a materialdifferent from the gel pad.
 4. The surgical access port of claim 1,wherein at least a portion of at least one of the sealing valvescomprises a duck bill valve in direct contact with the gel pad.
 5. Thesurgical access port of claim 1, wherein at least one of the sealingvalves has a first size to accommodate an instrument of the first size,and at least another of the sealing valves has a second size toaccommodate an instrument of the second size, the at least another ofthe sealing valves of the second size having a diameter larger than adiameter of the at least one of the sealing valves of the first size. 6.The surgical access port of claim 1, wherein at least one of the sealingvalves is configured such that the sealing valve is repositionablerelative to the cap ring during use.
 7. The surgical access port ofclaim 1, wherein at least one of the sealing valves is configured suchthat the sealing valve is translatable relative to the cap ring duringuse.
 8. The surgical access port of claim 1, wherein at least one of thesealing valves is configured such that the sealing valve is pivotablerelative to the cap ring during use.
 9. The surgical access port ofclaim 1, wherein at least one of the sealing valves is configured suchthat the sealing valve is held generally stationary relative to the capring during use.
 10. The surgical access port of claim 1, wherein thegel cap is configured to be removably coupled to the proximal ringduring use.
 11. The surgical access port of claim 1, wherein the gel capis fixed to the proximal ring.
 12. The surgical access port of claim 1,wherein the proximal ring of the wound retractor is rotatable toadjustably retract the incision during use.
 13. The surgical access portof claim 1, wherein the retraction sheath is stretchable to adjustablyretract the incision during use.
 14. The surgical access port of claim1, additionally comprising a tether coupled to the distal ring.
 15. Thesurgical access port of claim 1, wherein at least a portion of thedistal ring has a non-circular cross section that facilitates foldingthe distal ring and insertion through the incision.
 16. The surgicalaccess port of claim 1, wherein the distal ring has a tear-drop-shapedcross section that facilitates folding the distal ring and insertionthrough the incision.
 17. The surgical access port of claim 1, whereinthe distal ring comprises at least one notch that facilitates folding ofthe distal ring and insertion through the incision.
 18. A surgicalaccess port adapted for performing a surgical procedure at an accesssite wherein a body cavity of a patient is pressurized with aninsufflation gas, the access port adapted to provide access to the bodycavity for surgical procedures while maintaining insufflation pressurein the body cavity, the surgical access port comprising: an adjustableretractor comprising: a proximal ring, wherein the proximal ring isconfigured to be disposed proximate the outer surface of the body cavityof the patient; a retraction sheath comprising a tubular wall, aproximal portion coupled to the proximal ring during use, and a distalportion, wherein the retraction sheath is configured to be disposedthrough an opening in the body cavity of the patient, and wherein theretraction sheath is adjustable to retract the opening in the bodycavity; and a distal ring coupled to the distal portion of theretraction sheath, wherein the distal ring is configured to be disposedproximate the inner surface of the body cavity of the patient; and asealing cap configured to be coupled to the proximal ring, comprising: acap ring substantially surrounding a flexible material disposed withinthe cap ring; and a sealing valve positioned within the cap ring andsubstantially surrounded by and operatively attached to the flexiblematerial, wherein the sealing valve at least partially forms an accesschannel through the flexible material, and wherein the sealing valve isconfigured to form a seal with an instrument extending through thesealing valve and form a seal in the absence of any instrument extendingthrough the sealing valve; wherein the sealing valve has a low profilewith an upper surface of the sealing valve being disposed below orflushed with an upper surface of the flexible material, the uppersurface of the flexible material being a single planar surface and thesealing valve being made of a material different from the flexiblematerial, wherein the flexible material comprises a gel.
 19. Thesurgical access port of claim 18, wherein the sealing valve isrepositionable relative to the cap ring during use.
 20. The surgicalaccess port of claim 18, wherein the sealing valve is translatablerelative to the cap ring during use.
 21. The surgical access port ofclaim 18, wherein the sealing valve is pivotable relative to the capring during use.
 22. The surgical access port of claim 18, wherein thesealing cap comprises a plurality of sealing valves positioned withinthe cap ring and substantially surrounded by the flexible material,wherein the plurality of sealing valves at least partially form aplurality of access channels through the flexible material, and whereineach of the plurality of sealing valves comprises a septum seal embeddedin the flexible material to form seals with instruments extendingthrough the sealing valves and a duckbill embedded in the flexiblematerial to form seals in the absence of any instruments extendingthrough the sealing valves.
 23. The surgical access port of claim 18,additionally comprising a tether coupled to the distal ring.
 24. Thesurgical access port of claim 18, wherein at least a portion of thedistal ring has a non-circular cross section that facilitates foldingthe distal ring and insertion through the incision.
 25. A surgicalaccess port adapted for performing laparoscopic surgical procedures atan access site wherein an incision is made in the abdominal wall of apatient and the abdominal cavity is pressurized with an insufflationgas, the access port adapted to provide access to the abdominal cavityfor surgical procedures while maintaining insufflation pressure in theabdominal cavity, the surgical access port comprising: an adjustablewound retractor having a proximal ring, a distal ring, and a retractionsheath extending between the proximal ring and the distal ring, theproximal ring being configured to be disposed proximate the outersurface of the abdominal wall of the patient, the distal ring beingconfigured to be disposed proximate the inner surface of the abdominalwall of the patient, and the retraction sheath comprising a tubular wallhaving a proximal portion coupled to the proximal ring during use and adistal portion coupled to the distal ring during use, wherein theretraction sheath is configured to be disposed through the incision andline the incision, and wherein the retraction sheath is adjustable toretract the incision; and a sealing cap configured to be coupled to theproximal ring during use, the sealing cap comprising a plurality ofsealing valves, wherein the plurality of sealing valves are attached toa flexible material that connects the plurality of sealing valves toeach other and the plurality of sealing valves being low profile with anupper surface of each of the plurality of sealing valves being disposedbelow or flushed with an upper surface of the flexible material, theupper surface of the flexible material being a single planar surface andthe plurality of sealing valves being made of a material different fromthe flexible material, wherein the plurality of sealing valves at leastpartially form a plurality of access channels through the sealing cap,wherein the plurality of sealing valves are configured to form sealswith instruments extending through the sealing valves and form seals inthe absence of any instruments extending through the sealing valves, andwherein at least one of the sealing valves is repositionable relative toat least another one of the sealing valves during use, wherein thesealing cap comprises a gel pad.
 26. The surgical access port of claim25, wherein the plurality of sealing valves comprises a first sealingvalve, a second sealing valve and a third sealing valve, the firstsealing valve having a diameter larger than the second sealing valve andbeing disposed in a center portion of the gel pad, the second and thirdsealing valves disposed in an portion of the gel pad surrounding thecenter portion of the gel pad.
 27. The surgical access port of claim 26wherein the second sealing valve has a diameter larger than the diameterof the third sealing valve.
 28. The surgical access port of claim 25,wherein the at least one repositionable sealing valve is translatablerelative to the at least another one of the sealing valves.
 29. Thesurgical access port of claim 25, wherein the at least onerepositionable sealing valve is pivotable relative to the at leastanother one of the sealing valves.
 30. The surgical access port of claim25, additionally comprising a tether coupled to the distal ring.
 31. Thesurgical access port of claim 25, wherein at least a portion of thedistal ring has a non-circular cross section that facilitates foldingthe distal ring and insertion through the incision.